DEPARTMENTAL PROTOCOL REVIEW (Student Version)

Texas Christian University

Fort Worth, Texas

DEPARTMENTAL PROTOCOL REVIEW (Student Version)

The TCU Institutional Review Board (IRB) is responsible for protecting the welfare and rights of the individuals who are subjects of any research conducted by faculty, staff, or students at TCU. Approval by the IRB must be obtained prior to initiation of a project, whether conducted on-campus or off-campus.Student research is encouraged at both the undergraduate and graduate level. Only Protocol Reviews submitted by TCU students as the Principal Investigator will be accepted for review by the Departmental IRB committee. Protocol Reviews submitted by faculty as Principal Investigators or projects that are considered above “minimal risk” need to be submitted to the TCU IRB Committee not the Departmental IRB Committee.

Please submit this protocol electronically to the Chair of your Department DRB committee. Also submit a consent document, HIPAA form if applicable, Protection of Human Subjects Training certificates, and any questionnaires, or other documents to be utilized in data collection. A template for the consent document and HIPAA form and instructions on how to complete the consentare available on the HCNHS website ( at the Student Research link. Once the DRB protocol has been submitted, you must allow at least two weeksfor the review and approval letter to be received.

1. Date:

1. Study Title:

1. Principal Investigator - must be a TCU student:

1. Department:

1. Other Investigators - list the faculty mentor first as well as other faculty, staff, and students conducting the study including those not affiliated with TCU:

1. Project Period:

1. Funding Agency: (if not applicable - put “NA”)

1. Amount Requested From Funding Agency: (if not applicable - put “NA”)

1. Due Date for Funding: (if not applicable - put “NA”)

1. Purpose- Describe the objectives and hypotheses of the study and what you expect to learn or demonstrate:

1. Background-Describe the theory or data supporting the objective(s) of the study and include a bibliography of key references as applicable:

1. ParticipantPopulation - Describe the characteristics of theparticipant population including the inclusion and exclusion criteria and the number of participants you plan to recruit:

1. Recruitment Procedure- Describe your recruitment strategies including how the potential subjects will be approached andprecautions that will be taken to minimize the possibility of undue influence or coercion.

1. Consenting Procedure - Describe the consenting procedure, whether participation is completely voluntary, whether the participants can withdraw at any time without penalty and the procedures for withdrawing, whether an incentive (describe it) will be offered for participation. If students are used as subjects, indicate an alternative in lieu of participation if course credit is provided for participation.If a vulnerable population is recruited, describe the measures that will be taken to obtain surrogate consent (e.g., cognitively impaired subjects) or assent from minors and permission from parents of minors.

1. Study Procedures- Provide a chronological description ofthe procedures, tests, andinterventions that will be implemented during the course of the study. Indicate the number of visits, length of each visit, and the time it would take to undergo the various tests, procedures, and interventions. If blood or tissue is to be collected, indicate exactly how much in simple terms. Flow diagrams may be used to clarify complex projects.

1. Data Analyses - Describe how you will analyze your data to answer the study question.

1. Potential Risks and Precautions to Reduce Risk-Indicate any physical, psychological, social, or privacy risk which the subject may incur. Risk(s) must be specified. Also, describe what measures have been or will be taken to prevent and minimize each of the risks identified. If any deception is to be used, describe it in detail and the plans for debriefing.

1. Procedures to Maintain Confidentiality - Describe how the data will be collected, de-identified, stored, used, and disposed to protect confidentiality. If protected health information is to be re-identified at a later date, describe the procedure for doing so. All signed consents and hard data must be stored for a minimum of 3 years in a locked filing cabinet (and locked room) in the principal investigator’soffice, or a storage closet at TCU. Your professional society may recommend keeping the materials for a longer period of time.

1. Potential Benefits- Describe the potential benefits of the research to the participants, to others with similar problems, and to society.

1. Training for Protecting Human Research Participants – Submit training certificates for all the study investigators. The training link is available on the TCU IRB webpage at:

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1. Checklist for the Items that Need to be Submitted: Please combine all the files into one pdf document before submitting the materials electronically to the Departmental Committee Chair. To prevent any delay in the approval of your protocol, use the most recent template for the protocol, consent document, and HIPAA form by downloading them from or each time you prepare your materials.

1. Protocol
2. Consent document
3. HIPPA form (if applicable)
4. Protecting Human Research Participants Training Certificate

for each investigator

1. Recruitment fliers, letters, ads, etc.
2. Questionnaires or other documents utilized in screening and

data collection

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